UTI Reference Standard: Delphi Method

NCT ID: NCT05365906

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-12

Study Completion Date

2023-02-23

Brief Summary

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This study is set up by an international core group consisting of infectious disease specialists, geriatricians, urologists, microbiologists, emergency physicians and primary care physicians to develop a consensus-based research definition of urinary tract infections. The absence of such a reference standard leads to misclassification bias and heterogeneity between studies making progress in the field of UTI difficult, for example with much needed near patient diagnostic tests.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Delphi-procedure consisting of four survey rounds

This study will use a modified Delphi approach, consisting of a set of iterative questionnaires. In round 1, an expert panel will grade the relevance of UTI-related items, after which a smaller core research team will compose a reference standard in a series of (online) meetings. In round 2, clinical vignettes will be used to party validate the reference standard and expert panel agreement with the new reference standard will be assessed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Medical specialist working in the following fields: infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care
* Clinical and/or research experience with urinary tract infections

Exclusion Criteria

* Residency not completed yet
* Working in a different field than described above
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Manu Bilsen, MD

MD, PhD student, Department of Infectious Diseases, Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manu Bilsen, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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nWMODIV2_2022007

Identifier Type: -

Identifier Source: org_study_id

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